Stikeman Elliott provides a full range of business and intellectual property law services to pharmaceutical, biotechnology and life science-based companies and their investors. We also advise companies in other industries on healthcare-related matters and act in connection with development and financing of healthcare infrastructure.
From life sciences start-ups to multinational corporations, our lawyers provide expert advice on regulatory, mergers, acquisitions, financings, securities, taxation, employment, licensing, strategic contracts and joint ventures (including shareholders' agreements), patent portfolio development, copyright and trademark issues, and much more. We also have significant experience conducting reviews of intellectual property assets, contractual obligations, corporate structures, and litigation portfolios of life sciences companies in support of mergers and acquisitions, financing, licensing and distribution arrangements, cross-licensing of product dossiers with Health Canada in order to receive Drug Identification Numbers and other major transactions.
With offices located in cities that dominate and regulate life sciences, biotech research and health-product manufacturing, we have developed extensive expertise in this sector. We act for companies and individuals in the health-care sector, including pharmaceutical companies, biotechnology companies, researchers, health-care facilities, and other organizations in the health-care sector.
We have developed particular expertise in biotechnology and pharmaceutical issues. Our regulatory lawyers assist a variety of clients, including large multinational drug companies, in attaining regulatory approval from Health Canada and other government agencies on new drug submissions, labelling, good manufacturing practices, and non-prescription drugs.
Regulatory Approvals Process
Our regulatory lawyers assist a variety of clients, including large multinational drug companies, in attaining regulatory approval from Health Canada and other government agencies on new drug submissions, new health products, medical devices, labelling, good manufacturing practices, and non-prescription drugs.
We have cultivated strong relationships with health sector regulators throughout our network of offices. Accordingly, we can assist clients in navigating the complex regulatory approval process for pharmaceutical and healthcare products. Our experience in advising clients with respect to the Canadian life sciences regulatory regime includes:
Food and Drugs Act Compliance
Pharmaceutical manufacturers are largely regulated in Canada by the Food and Drugs Act and its associated regulations. We advise pharmaceutical clients on the full range of compliance considerations under this legislation, including:
- providing advice on NDS and ANDS submissions, including working with regulatory consultants in the preparation of submissions as necessary;
- providing advice on issues such as Canadian Reference Products, bioequivalence testing and regulatory amendment;
- assisting in meeting regulatory requirements to obtain approval for DINs and notices of compliance;
- advising on product licensing and labelling considerations;
- reviewing marketing and advertising materials to ensure compliance with legislation and industry codes;
- advising on clinical trial compliance; and
- challenging Health Canada decisions related to the legislation in Federal Court and Federal Court of Appeal.
Stikeman Elliott has extensive experience dealing with Health Canada on the approval and regulation of therapeutic drugs, including generic products. We also work for pharmaceutical and biotechnology companies in respect of Health Canada appeals and judicial review of Health Canada decisions on drug approvals. We have also made representations for clients to Health Canada on its "look-alike, sound-alike" regulations.
Patented Medicine Prices Review Board
Our experience with respect to the PMPRB is rooted in both advising clients with respect to pharmaceutical prices and in representing clients in disputes with Board. Depending on the nature of their patent strategy and portfolio, generic companies are increasingly coming under scrutiny by the PMPRB.
Patented Medicines (Notice of Compliance) Regulations litigation
We have acted successfully for generic pharmaceutical companies in PM(NOC) litigation, both with respect to contested mandates and in settlement of proceedings on mutually agreeable terms that avoid litigation.
We advise pharmaceutical wholesalers and manufacturers with respect to compliance with legislation and regulations governing the provincial formularies, such as the Ontario Drug Benefit Program, including the use of discounts, rebates and professional allowances, and including advising with respect to the regulatory requirements for pharmaceutical pricing in Quebec under the Régie de l'assurance maladie du Québec Act, the Prescription Drug Insurance Act and Regulation respecting the conditions governing the accreditation of manufacturers and wholesalers of medications.
In addition to assisting with clinical trial compliance under the Food and Drugs Act, we are experienced in the preparation and review of Canadian clinical trial agreements between sponsors, contract research organizations (CROs) and investigators, including sponsor initiated trial agreements and investigator initiated trial agreements.
Labelling & Marketing Matters
We advise pharmaceutical, medical device and other life sciences companies in respect of labelling and marketing issues, including compliance under the Food and Drugs Act, the Consumer Packaging and Labelling Act and industry codes. This is an area in which we can provide direct compliance advice to the client's business and marketing team, which may include seminars or workshops.
Intellectual Property Matters
Stikeman Elliott has assisted companies in the pharmaceutical, biotechnology and healthcare sectors in the acquisition, commercial exploitation and protection of their intellectual property. The services we provide fall into three core areas: (i) obtaining and perfecting intellectual property rights through preparation and prosecution of patent, trademark, copyright and industrial design applications; (ii) commercial exploitation of intellectual property rights through a variety of business instruments including the acquisition and licensing of intellectual property assets; and (iii) enforcing intellectual property rights primarily through litigation.
Our group includes a number of leading practitioners in the intellectual property field in Canada who have appeared as counsel in significant litigation and who have been involved in some of Canada's most significant commercial transactions. Our lawyers have appeared before the Federal Court of Canada, the Federal Court of Appeal, the Supreme Court of Canada, the Patent Medicines Prices Review Board, the Trademarks Opposition Board, and the Copyright Board.
Litigation and Class Actions
Our class action practice in the pharmaceutical and healthcare sector is grounded in the experience and expertise of our leading litigators. Stikeman Elliott frequently acts on behalf of pharmaceutical companies, medical device manufacturers and healthcare service providers in the defence of class actions brought against them. The hallmark of our service is our quick and reasoned assessment of strategic options on behalf of our clients, and our ability to understand and present the often complex terms and processes that are germane to litigation in this sector. Most recently, we have acted in connection with class action matters on behalf of Ranbaxy, Wyeth, Medtronic and Purdue Pharma, among others.
We have been highly active in the growth of innovative financing for healthcare infrastructure development in Canada, including Public-Private Partnership financing completed on any combination of Design, Build, Finance, Operate and Maintain models. We have acted for developers, lenders and sponsors in a variety of hospital, research facility and long-term care facility development projects.